ruptured anterior cruciate ligament
Conditions
Interventions
ACL reconstruction with the L-C ligament.
Sponsors
Biorez, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 18 to 45 years of age. Males and females. If female, for the 24 months post-operative, actively practicing a contraception method, or surgically sterilised or postmenopausal. Acute unilateral ACL tear, or partial or complete tear of the ACL that occurred within 91 days (13 weeks) of injury, and requires reconstruction of the ACL. Passive flexion - 120° and passive extension on the target knee is the same as the contralateral knee. Patients with all types of lateral and/or medial meniscal tears which are repairable. Medial Collateral Ligament (MCL) grade 2 or less. Potential Subject is able to provide informed consent and must sign the EC-approved Informed Consent Form Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical, radiographic and rehabilitation follow up visits through 24 months.
Exclusion criteria
Exclusion criteria: Prior ACL reconstruction or other surgical procedure on the affected (target) knee. Chronic ACL injury; interventional surgery scheduled 92 days or more after ACL injury. Professional athletes currently engaged in active sport Prior fracture of the affected (target) leg Previous or current ACL injury on contra-lateral leg. Multi-ligament reconstruction. Malalignment with varus thrust Patient > 193 cm tall (6* 4*). The patient does not follow pre-operative rehabilitation. Confirmed connective tissue disorder. Signs of moderate to severe degenerative joint disease (Osteoarthritis) Concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion. Severe pain, swelling, or redness within 24 hours prior to surgery. Complete or partial Post Cruciate Ligament (PCL) tear. Any of the following: 1/3rd meniscal resection; complex doublebucket tear; partially repaired meniscal tears. Patient requires treatment of articular cartilage on target leg The patient is mentally compromised. The patient has a neuromuscular disorder that would engender unacceptable risk of knee instability, prosthesis fixation failure, or complications in postoperative care. The patient has a diagnosed systemic disease that would affect his/her safety or the study outcome. The patient has an active or latent infection in or about the affected knee joint or an infection site distant from the knee that may spread to the knee hematogenously. Pregnant based on a positive beta hCG serum or an in vitro diagnostic test result or breast-feeding. The patient is obese with a BMI ³ 35. The patient has a known allergy to PLLA. The patient has a medical condition or comorbidity that would interfere with study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Absence of graft failure (attributed to the device) at one year * Absence of revision ACL surgery at one year post-procedure required due to any of the following: * Tear or rupture in the graft * Serious infection attributed to the L-C Ligament * Substantial laxity attributed to loss of fixation in the femoral or tibial tunnels directly attributed to the L-C Ligament | — |
Secondary
| Measure | Time frame |
|---|---|
| The following variables will be analyzed for informational purposes: - Clinical function as assessed by the 2000 IKDC scale at pre-op, post-op, 3, 6, 12, 18 and 24 months. - Safety rates per intra- and post- operative complications. - KOOS Pain, Tegner and Lysholm scores pre-op, post-op, 3, 6, 12, 18 and 24 months and 3 ,4 and 5 years. - Radiographic, MRI, and CT assessment of the position of the femoral & tibial tunnels, indirect evidence of ligament tissue remodeling, and evidence of tunnel-widening. - Clinical function measured with the Lachman, anterior drawer, KT1000*, pivot-shift, and single-leg hop tests at pre-op, 6, 12, 18 and 24 months (and optionally at Years 3, 4, and 5). | — |
Countries
Netherlands
Outcome results
None listed